Manufacturing Engineer

AtriCure • Mason, OH

16d

About The Position

The Manufacturing Engineer is responsible for the development, qualification, verification and validation of manufacturing processes. The Manufacturing Engineer will contribute in creative and collaborative way to achieve the company’s goals of producing market lead products through positive patient outcomes.

Requirements

• Bachelor’s degree in engineering (mechanical, industrial, or related field) required or demonstrated equivalent combination of education, training, and experience
• 3+ years of experience in a comparable position
• Able to function as lead manufacturing engineer for product development teams with minimal guidance
• Demonstrates proficiency in selection and qualification of manufacturing processes
• Able to provide input into the design of the product based on manufacturing methods and capabilities
• Able to review product designs relative to achievable component and system tolerances
• Demonstrates proficiency in coordinating the design and development of equipment and fixtures
• Demonstrates proficiency in developing and executing process qualification strategies
• Understands the importance of manufacturing documentation, and sufficient understanding of manufacturing logistics to guide strategy decisions by the design teams
• Conveys ability to work and communicate in a cross-functional environment, including Marketing, Quality, Manufacturing, and Regulatory departments
• Demonstrates the ability to plan and track tasks to align with project plan and team objectives
• Inspection/testing experience
• Data analysis experience
• Computer/data entry skills
• Written/report writing skills
• Verbal communication skills
• Problem solving/troubleshooting experience
• Ability to read technical specifications
• Ability to read blueprints, drawings, and specifications
• Ability to regularly walk, sit, or stand as needed
• Ability to occasionally bend and push/pull as needed
• Ability to pass pre-employment drug screen and background check

Nice To Haves

• Graduate degree
• Assembly and machining experience
• Regulatory experience
• Statistical use experience
• medical device industry experience
• Financial analysis experience

Responsibilities

• Team member of projects involving design and manufacturing resources, both internal and external.
• Review of component designs and identification of Design for Manufacturing opportunities.
• Review of proposed component tolerances and input to manufacturing capability.
• Review of proposed device assembly requirements and identification of Design for Assembly opportunities.
• Provide input to systems test requirements for ongoing production
• Definition of high-level manufacturing system/flow
• Selection of suppliers for parts and equipment
• Coordination of parts and equipment fabrication
• Knowledge of general manufacturing technologies including low to medium volume manufacturing processes
• Work with outside suppliers to define, document, analyze and qualify their manufacturing processes
• Identify new vendors, processes, materials, and technologies that can be used to improve product quality and reduce product cost
• Lead the definition, development, verification, and validation of manufacturing processes for new products. Develop manufacturing processes that are simple, cost-effective and reliable
• Identify and implement manufacturing and product-related cost reduction opportunities. Understand life-cycle costs and cost-benefit analysis
• Familiar with manufacturing efficiency strategies such as Lean, Six Sigma, 5S, Value Stream mapping, etc.
• Able to define, communicate, and develop fixture concepts using internal and external resources. Able to incorporate the capabilities of typical production association into these concepts
• Work with designers and engineers in the design and development of manufacturing-related equipment and fixtures
• Define and track project tooling and equipment schedule and cost
• Responsible for proper installation of new equipment, and setting up proper preventive maintenance and calibration plans
• Responsible for developing detailed process qualification strategies. Able to define statistical sample sizes as related to variable and attribute data, based on established company and industry standards
• Responsible for developing detailed Process FMEAs and using the output to develop robust manufacturing processes. Also using the output to determine in-process testing and product final inspection requirements
• Responsible for writing and executing process qualification protocols and reports. Understanding of IQ, OQ, and PQ approach as defined by AtriCure Quality System
• Understand supply chains, lead times, and raw material availability
• Responsible for make vs. buy decisions on parts and processes
• Able to construct Bills of Material, with proper unit of measure and inventory points
• Working knowledge of MRP and other requirement planning systems
• Able to create manufacturing routers. Understands labor collection and work centers
• Understanding of standard costing and variances. Able to conduct time studies and analyze cost variances
• Properly document all work in compliance with AtriCure Quality System requirements
• Responsible for process documentation release using tools such as Visio, Excel, Word, Procal and Master Control documentation release systems
• Write detailed, easy to understand process instructions
• Write detailed test protocols and reports to document qualification activities
• Develop process maps and FMEAs for all processes
• Responsible for communication of manufacturing and process issues to cross functional development team and suppliers, both verbally and in written documentation
• The individual must have proficiency in computer communication tools and design documentation (Microsoft Office products)
• In charge of planning work to track tasks that align with project plan and team objectives
• Develop and communicate best practices among other manufacturing engineers
• Responsible for guiding the efforts of more junior manufacturing engineers and technicians
• Regular and predictable worksite attendance
• Ability to work under fast-paced conditions
• Ability to make decisions and use good judgement
• Ability to prioritize various duties and multitask as required
• Ability to successfully work with others
• Additional duties as assigned

Benefits

• Medical & Dental beginning day 1 of employment
• 401K plus match
• 30 days of paid Parental Leave, in addition to maternity leave, for new moms and dads
• Volunteer Time off
• Pet Insurance
• on-site fitness center and cafeteria

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Number of Employees: 501-1,000 employees